NCT06671418Enrolling by invitationPhase 3
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
Source: ClinicalTrials.gov · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is: To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection. Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur. Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 1 Nov 2024
- Start date
- 9 Aug 2023
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Erasmus Medical Center
- NCT number
- NCT06671418
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 148
- From 9 Aug 2023 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed.
Other illness
- Uncorrectable coagulation disorder.
- Uncorrectable contrast allergy.
Lab values
- Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis.
Other
- Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22).
Who the study is looking for
- Written informed consent must be given according to ICH/GCP and national/local regulations.
- MHBO on imaging with histopathological confirmation or high clinical suspicion.
- Ineligible for surgical resection.
- Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.